FDA clears Resonance Health's MRI-Q System for cardiac T2* iron assessment

Resonance Health Ltd, a medical device company specializing in imaging core laboratory services has received FDA clearance to market its MRI-Q System. The test measures cardiac T2* which is a highly sensitive surrogate marker for cardiac iron.

Resonance Health's other product on market is FerriScan^® R2-MRI (www.ferriscan.com), which provides an accurate assessment of liver iron concentration (LIC). The MRI-Q system provides an opportunity to broaden the Company's range of solutions to address the iron overload market.

Iron overload can occur in patients who are dependent on blood transfusions for the treatment of conditions such as thalassemia, sickle cell disease and myelodysplastic syndrome. It can also be caused by excessive dietary absorption of iron through hereditary hemochromatosis, one of the most common genetic disorders in the United States. Iron overload can result in organ damage and the accumulation of cardiac iron is the leading cause of death in patients with β-thalassemia major.

FerriScan R2-MRI and now the MRI-Q system are provided to the market as a combined service for both the liver and cardiac T2* iron assessment. To access FerriScan R2-MRI and MRI-Q, an MRI center transmits image data electronically via a secure internet portal to the Company's quality-controlled, ISO9001 certified central core lab where experts conduct the analysis. Resonance Health can now provide clinicians with added value by including both liver iron and cardiac T2* results in the data analysis.

"Customers can start using the service immediately," said Liza Dunne, Managing Director. "There are no additional software or hardware purchases needed and the price of MRI-Q and FerriScan R2-MRI is charged on a "per-scan" basis. FerriScan R2-MRI is currently used by global pharmaceutical companies in multicenter clinical trials for iron chelation therapy products and by several hospitals in the United States. Cardiac iron assessments will be delivered with the same standards of quality and consistency that clinicians have come to expect from FerriScan R2-MRI."

Resonance Health is also developing technology for the quantitative MRI-based measurement of fatty liver and liver fibrosis and welcomes collaborations in these fields.